510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DSKClass II

Computer, Blood-Pressure

21 CFR 870.1110 / Cardiovascular
FDA source (opens on fda.gov)

DSK is the FDA product code for Computer, Blood-Pressure, a class II device type, regulated under 21 CFR 870.1110. As of , FDA records hold 77 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DSK
Device name
Computer, Blood-Pressure
Regulation
21 CFR 870.1110
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
77
Ingested recalls
1

Clearances, product code DSK

By decision year
77 clearances under product code DSK with a decision year between 1977 and 2023, 1981 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code DSK by decision year
YearClearances
19771
19789
19795
19804
198110
19822
19832
19853
19864
19875
19884
19894
19902
19912
19921
19933
19941
19961
19991
20015
20021
20041
20071
20081
20152
20161
20231

Applicants with the most clearances

Product code DSK
Applicants holding the most 510(k) clearances under product code DSK
ApplicantClearances
A and D Engineering, Inc.6
Applied Medical Research5
Honeywell, Inc.4
Datex Division Instrumentarium Corp.3
Associated Mills, Inc.2
ATCOR MEDICAL Pty Ltd2
Camino Laboratories, Inc.2
Hewlett-Packard Co.2
Medtel Pty., Ltd.2
Output, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 85 companies shown, in name order